NANT 2011-04: A Phase I Study of Lenalidomide and Anti-GD2 Mab Ch14.18 +/- Isotretinoin in Patients With Refractory/Recurrent Neuroblastoma.
What is the purpose of this study?
This phase I trial studies the side effects and best dose of lenalidomide when given together with monoclonal antibody with or without isotretinoin in treating younger patients with refractory or recurrent neuroblastoma. Drugs used in chemotherapy, such as lenalidomide and isotretinoin, work in different wants to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as monoclonal antibody Ch14.18, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with monoclonal antibody therapy may kill more tumor cells.
Who can participate?
Patients of ages up to 21 years may participate in this study:
- Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
- Patients must have high-risk neuroblastoma
What is involved?
This is a
dose-escalation study of lenalidomide.
lenalidomide orally (PO) once daily (QD) on days 1-21, monoclonal antibody
Ch14.18 IV over 10 hours on days 8-11, and isotretinoin PO twice daily (BID) on
days 15-28 of dose levels 2-5. Treatment repeats every 28 days for up to 6
courses in the absence of disease progression or unacceptable toxicity.
After completion of
study treatment, patients are followed up periodically.
Who should I contact for more information?
For more information contact:
Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Where can I find additional information?